Ignite Creation Date:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT01863693
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2013-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy as First-Line Treatment in Patients With Advanced Ovarian Cancer (OSCAR 1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2013-05-23', 'studyFirstSubmitQcDate': '2013-05-23', 'lastUpdatePostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival, defined as time from first administration of first-line therapy to documented disease progression', 'timeFrame': 'approximately 6 years'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 6 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival, defined as time from first administration of first-line therapy to documented death', 'timeFrame': 'approximately 6 years'}, {'measure': 'Objective response rate, defined as percentage of patients with complete or partial response according to local assessments', 'timeFrame': 'approximately 6 years'}, {'measure': 'Quality of life: EQ-5D/EORTC questionnaires', 'timeFrame': 'approximately 6 years'}, {'measure': 'Dosage/schedule/duration of Avastin therapy', 'timeFrame': 'approximately 6 years'}, {'measure': 'Composition of first-line chemotherapy regimens: drugs/dosage/duration', 'timeFrame': 'approximately 6 years'}]}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '31780570', 'type': 'DERIVED', 'citation': 'Hall M, Bertelli G, Li L, Green C, Chan S, Yeoh CC, Hasan J, Jones R, Ograbek A, Perren TJ. Role of front-line bevacizumab in advanced ovarian cancer: the OSCAR study. Int J Gynecol Cancer. 2020 Feb;30(2):213-220. doi: 10.1136/ijgc-2019-000512. Epub 2019 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'This multicenter, prospective, observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with chemotherapy as first-line treatment in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in routine clinical practice. Eligible patients will be followed for approximately 15 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer undergoing first-line treatment with chemotherapy and Avastin', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube or primary peritoneal cancer not previously treated with chemotherapy\n* Initiating Avastin in combination with chemotherapy\n\nExclusion Criteria:\n\n* Contraindications, warnings and precautions for use as specified in the Avastin Summary of Product Characteristics'}, 'identificationModule': {'nctId': 'NCT01863693', 'briefTitle': 'An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy as First-Line Treatment in Patients With Advanced Ovarian Cancer (OSCAR 1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'AN OBSERVATIONAL STUDY OF AVASTIN® (BEVACIZUMAB) AS FIRST LINE THERAPY IN PATIENTS WITH ADVANCED OVARIAN CANCER', 'orgStudyIdInfo': {'id': 'ML28570'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BA1 3NG', 'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Royal United Hospital; Oncology Department', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'B18 7QH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'City Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BD9 6RJ', 'city': 'Bradford', 'country': 'United Kingdom', 'facility': 'Bradford Royal Infirmary; Oncology Department', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'zip': 'BS2 8ED', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Haematology and Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'DE13 0RB', 'city': 'Burton-on-Trent', 'country': 'United Kingdom', 'facility': "Queen's Hospital; Oncology Department", 'geoPoint': {'lat': 52.80728, 'lon': -1.64263}}, {'zip': 'CO3 3NB', 'city': 'Colchester', 'country': 'United Kingdom', 'facility': 'Essex County Hospital', 'geoPoint': {'lat': 51.88921, 'lon': 0.90421}}, {'zip': 'BN21 2UD', 'city': 'Eastbourne', 'country': 'United Kingdom', 'facility': 'Eastborne District General Hospital', 'geoPoint': {'lat': 50.76871, 'lon': 0.28453}}, {'zip': 'EX2 5DW', 'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Wonford Hospital; Oncology Department', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'GU2 7XX', 'city': 'Guildford', 'country': 'United Kingdom', 'facility': 'Royal Surrey County Hospital', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'IP4 5PD', 'city': 'Ipswich', 'country': 'United Kingdom', 'facility': 'Ipswich Hospital', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'zip': 'BD20 6TD', 'city': 'Keighley', 'country': 'United Kingdom', 'facility': 'Airedale General Hospital; Research Office Ward 12', 'geoPoint': {'lat': 53.86791, 'lon': -1.90664}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'St James University Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital - London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'ME16 0FS', 'city': 'Maidstone', 'country': 'United Kingdom', 'facility': 'Maidstone Hospital; Kent Oncology Centre', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'zip': 'M2O 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Christie Hospital Nhs Trust; Medical Oncology', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'L63 4JY', 'city': 'Metropolitan Borough of Wirral', 'country': 'United Kingdom', 'facility': 'The Clatterbridge Cancer Centre NHS Foundation Trust', 'geoPoint': {'lat': 53.37616, 'lon': -3.10501}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'The James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'HA6 2RN', 'city': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Mount Vernon Hospital', 'geoPoint': {'lat': 51.53174, 'lon': -0.26856}}, {'zip': 'PO30 5TG', 'city': 'Newport', 'country': 'United Kingdom', 'facility': "St Mary's Hospital", 'geoPoint': {'lat': 51.58774, 'lon': -2.99835}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'City Campus; Academic Unit of Oncology', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'PO6 3LY', 'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'zip': 'S10 2SJ', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Weston Park Hospital; Cancer Clinical Trials Centre', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'ST4 6QG', 'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'City General Hospital', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'country': 'United Kingdom', 'facility': 'The Royal Marsden Hospital', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'SA2 8QA', 'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Singleton Hospital; Oncology', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'zip': 'TQ27AA', 'city': 'Torquay', 'country': 'United Kingdom', 'facility': 'Torbay Hospital; Oncology Department', 'geoPoint': {'lat': 50.46198, 'lon': -3.52522}}, {'zip': 'TR1 3LQ', 'city': 'Truro', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'New Cross Hospital; Deansley Centre', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}, {'zip': 'YO31 8HE', 'city': 'York', 'country': 'United Kingdom', 'facility': 'The York Hospital', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}